Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Secondary Outcome Measures:

Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] [ Designated as safety issue: No ]

Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] [ Designated as safety issue: No ]

Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] [ Designated as safety issue: No ]

Time from start of study treatment to disease progression per independent review group or death due to any cause.

Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Area Under the Curve [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.

Documented anaplastic lymphoma kinase (ALK) status.

Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.

Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.

At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

Previous treatment with brentuximab vedotin.

Previously received an allogeneic transplant.

Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).

Known cerebral/meningeal disease.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866047